[United States Statutes at Large, Volume 122, 110th Congress, 2nd Session]
[From the U.S. Government Printing Office, www.gpo.gov]
122 STAT. 3509
Public Law 110-316
110th Congress
An Act
To amend the Federal Food, Drug, and Cosmetic Act to revise and extend
the animal drug user fee program, to establish a program of fees
relating to generic new animal drugs, to make certain technical
corrections to the Food and Drug Administration Amendments Act of 2007,
and for other purposes. [NOTE: Aug. 14, 2008 - [H.R. 6432]]
Be it enacted by the Senate and House of Representatives of the
United States of America in Congress assembled,
SECTION 1. TABLE OF CONTENTS.
The table of contents of this Act is as follows:
Sec. 1. Table of contents.
Sec. 2. References in Act.
TITLE I--ANIMAL DRUG USER FEE AMENDMENTS
Sec. 101. Short title; finding.
Sec. 102. Definitions.
Sec. 103. Authority to assess and use animal drug fees.
Sec. 104. Reauthorization; reporting requirements.
Sec. 105. Antimicrobial animal drug distribution reports.
Sec. 106. Savings clause.
Sec. 107. Effective date.
Sec. 108. Sunset dates.
TITLE II--ANIMAL GENERIC DRUG USER FEE
Sec. 201. Short title; findings.
Sec. 202. Fees relating to abbreviated applications for generic new
animal drugs.
Sec. 203. Accountability and reports.
Sec. 204. Sunset dates.
TITLE III--TECHNICAL CORRECTIONS TO FDAAA
Sec. 301. Consideration of certain petitions.
Sec. 302. Registry and results data bank.
SEC. 2. REFERENCES IN ACT.
Except as otherwise specified, amendments made by this Act to a
section or other provision of law are amendments to such section or
other provision of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
301 et seq.).
TITLE I--ANIMAL [NOTE: Animal Drug User Fee Amendments of 2008.] DRUG
USER FEE AMENDMENTS
SEC. 101. SHORT TITLE; FINDING.
(a) [NOTE: 21 USC 301 note.] Short Title.--This title may be
cited as the ``Animal Drug User Fee Amendments of 2008''.
(b) [NOTE: 21 USC 379j-11 note.] Finding.--Congress finds that
the fees authorized by the amendments made in this title will be
dedicated toward expediting
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122 STAT. 3510
the animal drug development process and the review of new and
supplemental animal drug applications and investigational animal drug
submissions as set forth in the goals identified, for purposes of part 4
of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic
Act, in the letters from the Secretary of Health and Human Services to
the Chairman of the Committee on Energy and Commerce of the House of
Representatives and the Chairman of the Committee on Health, Education,
Labor, and Pensions of the Senate as set forth in the Congressional
Record.
SEC. 102. DEFINITIONS.
Section 739 (21 U.S.C. 379j-11) is amended--
(1) in paragraph (6), by striking ``, except for an approved
application for which all subject products have been removed
from listing under section 510'' and inserting ``that has not
been withdrawn by the applicant and for which approval has not
been withdrawn by the Secretary'';
(2) in paragraph (8)(H), by striking ``but not such
activities after an animal drug has been approved'' and
inserting ``but not after such application has been approved'';
(3) in paragraph (10), by striking ``year being 2003'' and
inserting ``month being October 2002'';
(4) by redesignating paragraph (11) as paragraph (12); and
(5) by inserting after paragraph (10) the following:
``(11) The term `person' includes an affiliate thereof.''.
SEC. 103. AUTHORITY TO ASSESS AND USE ANIMAL DRUG FEES.
(a) Types of Fees.--Section 740(a) (21 U.S.C. 379j-12(a)) is
amended--
(1) in paragraph (1)(A)(i), by inserting after ``for an
animal drug application'' the following: ``, except an animal
drug application subject to the criteria set forth in section
512(d)(4)''; and
(2) by amending paragraph (1)(A)(ii) to read as follows:
``(ii) A fee established in subsection (b), in
an amount that is equal to 50 percent of the
amount of the fee under clause (i), for--
``(I) a supplemental animal drug
application for which safety or
effectiveness data are required; and
``(II) an animal drug application
subject to the criteria set forth in
section 512(d)(4).''.
(b) Fee Amounts.--
(1) Total fee revenues for application and supplement
fees.--Section 740(b)(1) (21 U.S.C. 379j-12(b)(1)) is amended--
(A) by striking ``and supplemental animal drug
application fees'' and inserting ``and supplemental and
other animal drug application fees''; and
(B) by striking ``$1,250,000'' and all that follows
through the period at the end and inserting ``$3,815,000
for fiscal year 2009, $4,320,000 for fiscal year 2010,
$4,862,000 for fiscal year 2011, $5,442,000 for fiscal
year 2012, and $6,061,000 for fiscal year 2013.''.
(2) Total fee revenues for product fees.--Section 740(b)(2)
(21 U.S.C. 379j-12(b)(2)) is amended by striking ``$1,250,000''
and all that follows through the period at the end and inserting
``$3,815,000 for fiscal year 2009, $4,320,000
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122 STAT. 3511
for fiscal year 2010, $4,862,000 for fiscal year 2011,
$5,442,000 for fiscal year 2012, and $6,061,000 for fiscal year
2013.''.
(3) Total fee revenues for establishment fees.--Section
740(b)(3) (21 U.S.C. 379j-12(b)(3)) is amended by striking
``$1,250,000'' and all that follows through the period at the
end and inserting ``$3,815,000 for fiscal year 2009, $4,320,000
for fiscal year 2010, $4,862,000 for fiscal year 2011,
$5,442,000 for fiscal year 2012, and $6,061,000 for fiscal year
2013.''.
(4) Total fee revenues for sponsor fees.--Section 740(b)(4)
(21 U.S.C. 379j-12(b)(4)) is amended by striking ``$1,250,000''
and all that follows through the period at the end and inserting
``$3,815,000 for fiscal year 2009, $4,320,000 for fiscal year
2010, $4,862,000 for fiscal year 2011, $5,442,000 for fiscal
year 2012, and $6,061,000 for fiscal year 2013.''.
(c) Adjustments to Fees.--Section 740(c) (21 U.S.C. 379j-12(c)) is
amended--
(1) by striking paragraph (1);
(2) by redesignating paragraphs (2) through (5) as
paragraphs (1) through (4), respectively;
(3) in paragraph (1), as so redesignated--
(A) in the matter preceding subparagraph (A), by
striking ``After the fee revenues are adjusted for
inflation in accordance with paragraph (1), the fee
revenues shall be further adjusted each fiscal year
after fiscal year 2004'' and inserting ``The fee
revenues shall be adjusted each fiscal year after fiscal
year 2009''; and
(B) in subparagraph (B), by striking ``, as adjusted
for inflation under paragraph (1)''; and
(4) in paragraph (2), as so redesignated--
(A) by striking ``2008'' each place it appears and
inserting ``2013''; and
(B) by striking ``2009'' and inserting ``2014''.
(d) Authorization of Appropriations.--Subparagraphs (A) through (E)
of section 740(g)(3) (21 U.S.C. 379j-12(g)(3)) are amended to read as
follows:
``(A) $15,260,000 for fiscal year 2009;
``(B) $17,280,000 for fiscal year 2010;
``(C) $19,448,000 for fiscal year 2011;
``(D) $21,768,000 for fiscal year 2012; and
``(E) $24,244,000 for fiscal year 2013;''.
(e) Offset.--Section 740(g)(4) (21 U.S.C. 379j-12(g)(4)) is amended
to read as follows:
``(4) Offset.--If the sum of the cumulative amount of fees
collected under this section for fiscal years 2009 through 2011
and the amount of fees estimated to be collected under this
section for fiscal year 2012 exceeds the cumulative amount
appropriated under paragraph (3) for the fiscal years 2009
through 2012, the excess amount shall be credited to the
appropriation account of the Food and Drug Administration as
provided in paragraph (1), and shall be subtracted from the
amount of fees that would otherwise be authorized to be
collected under this section pursuant to appropriation Acts for
fiscal year 2013.''.
SEC. 104. REAUTHORIZATION; REPORTING REQUIREMENTS.
Part 4 of subchapter C of chapter VII (21 U.S.C. 379j-11 et seq.) is
amended by inserting after section 740 the following:
[[Page 3512]]
122 STAT. 3512
``SEC. 740A. [NOTE: Effective dates. 21 USC 379j-13.]
REAUTHORIZATION; REPORTING REQUIREMENTS.
``(a) Performance Report.--Beginning with fiscal year 2009, not
later than 60 days after the end of each fiscal year during which fees
are collected under this part, the Secretary shall prepare and submit to
the Committee on Energy and Commerce of the House of Representatives and
the Committee on Health, Education, Labor, and Pensions of the Senate a
report concerning the progress of the Food and Drug Administration in
achieving the goals identified in the letters described in section
101(b) of the Animal Drug User Fee Amendments of 2008 toward expediting
the animal drug development process and the review of the new and
supplemental animal drug applications and investigational animal drug
submissions during such fiscal year, the future plans of the Food and
Drug Administration for meeting the goals, the review times for
abbreviated new animal drug applications, and the administrative
procedures adopted by the Food and Drug Administration to ensure that
review times for abbreviated new animal drug applications are not
increased from their current level due to activities under the user fee
program.
``(b) Fiscal Report.--Beginning with fiscal year 2009, not later
than 120 days after the end of each fiscal year during which fees are
collected under this part, the Secretary shall prepare and submit to the
Committee on Energy and Commerce of the House of Representatives and the
Committee on Health, Education, Labor, and Pensions of the Senate a
report on the implementation of the authority for such fees during such
fiscal year and the use, by the Food and Drug Administration, of the
fees collected during such fiscal year for which the report is made.
``(c) Public Availability.--The [NOTE: Web site.] Secretary shall
make the reports required under subsections (a) and (b) available to the
public on the Internet Web site of the Food and Drug Administration.
``(d) Reauthorization.--
``(1) Consultation.--In [NOTE: Recommenda- tions.]
developing recommendations to present to the Congress with
respect to the goals, and plans for meeting the goals, for the
process for the review of animal drug applications for the first
5 fiscal years after fiscal year 2013, and for the
reauthorization of this part for such fiscal years, the
Secretary shall consult with--
``(A) the Committee on Energy and Commerce of the
House of Representatives;
``(B) the Committee on Health, Education, Labor, and
Pensions of the Senate;
``(C) scientific and academic experts;
``(D) veterinary professionals;
``(E) representatives of patient and consumer
advocacy groups; and
``(F) the regulated industry.
``(2) Prior public input.--Prior to beginning negotiations
with the regulated industry on the reauthorization of this part,
the Secretary shall--
``(A) [NOTE: Notice. Federal Register,
publication.] publish a notice in the Federal Register
requesting public input on the reauthorization;
``(B) hold a public meeting at which the public may
present its views on the reauthorization, including
specific suggestions for changes to the goals referred
to in subsection (a);
[[Page 3513]]
122 STAT. 3513
``(C) provide a period of 30 days after the public
meeting to obtain written comments from the public
suggesting changes to this part; and
``(D) [NOTE: Web site.] publish the comments on
the Food and Drug Administration's Internet Web site.
``(3) Periodic consultation.--Not [NOTE: Deadlines.] less
frequently than once every 4 months during negotiations with the
regulated industry, the Secretary shall hold discussions with
representatives of veterinary, patient, and consumer advocacy
groups to continue discussions of their views on the
reauthorization and their suggestions for changes to this part
as expressed under paragraph (2).
``(4) Public review of recommendations.--After negotiations
with the regulated industry, the Secretary shall--
``(A) present the recommendations developed under
paragraph (1) to the Congressional committees specified
in such paragraph;
``(B) [NOTE: Federal Register, publication.]
publish such recommendations in the Federal Register;
``(C) [NOTE: Comments.] provide for a period of
30 days for the public to provide written comments on
such recommendations;
``(D) hold a meeting at which the public may present
its views on such recommendations; and
``(E) after consideration of such public views and
comments, revise such recommendations as necessary.
``(5) Transmittal of recommendations.--
Not [NOTE: Deadline.] later than January 15, 2013, the
Secretary shall transmit to the Congress the revised
recommendations under paragraph (4), a summary of the views and
comments received under such paragraph, and any changes made to
the recommendations in response to such views and comments.
``(6) Minutes of negotiation meetings.--
``(A) Public availability.--Before [NOTE: Web
site.] presenting the recommendations developed under
paragraphs (1) through (5) to the Congress, the
Secretary shall make publicly available, on the Internet
Web site of the Food and Drug Administration, minutes of
all negotiation meetings conducted under this subsection
between the Food and Drug Administration and the
regulated industry.
``(B) Content.--The minutes described under
subparagraph (A) shall summarize any substantive
proposal made by any party to the negotiations as well
as significant controversies or differences of opinion
during the negotiations and their resolution.''.
SEC. 105. ANTIMICROBIAL ANIMAL DRUG DISTRIBUTION REPORTS.
(a) Reports.--Section 512(l) (21 U.S.C. 360b(l)) is amended by
adding at the end the following:
``(3)(A) In the case of each new animal drug described in paragraph
(1) that contains an antimicrobial active ingredient, the sponsor of the
drug shall submit an annual report to the Secretary on the amount of
each antimicrobial active ingredient in the drug that is sold or
distributed for use in food-producing animals, including information on
any distributor-labeled product.
``(B) Each report under this paragraph shall specify the amount of
each antimicrobial active ingredient--
``(i) by container size, strength, and dosage form;
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122 STAT. 3514
``(ii) by quantities distributed domestically and quantities
exported; and
``(iii) by dosage form, including, for each such dosage
form, a listing of the target animals, indications, and
production classes that are specified on the approved label of
the product.
``(C) Each report under this paragraph shall--
``(i) be submitted not later than March 31 each year;
``(ii) cover the period of the preceding calendar year; and
``(iii) include separate information for each month of such
calendar year.
``(D) The Secretary may share information reported under this
paragraph with the Antimicrobial Resistance Task Force established under
section 319E of the Public Health Service Act.
``(E) [NOTE: Public information.] The Secretary shall make
summaries of the information reported under this paragraph publicly
available, except that--
``(i) the summary data shall be reported by antimicrobial
class, and no class with fewer than 3 distinct sponsors of
approved applications shall be independently reported; and
``(ii) the data shall be reported in a manner consistent
with protecting both national security and confidential business
information.''.
(b) [NOTE: 21 USC 360b note.] First Report.--For each new animal
drug that is subject to the reporting requirement under section
512(l)(3) of the Federal Food, Drug, and Cosmetic Act, as added by
subsection (a), and for which an approval of an application filed
pursuant to section 512(b) or 571 of such Act is in effect on the date
of the enactment of this title, the Secretary of Health and Human
Services shall require the sponsor of the drug to submit the first
report under such section 512(l)(3) for the drug not later than March
31, 2010.
(c) Separate Report.--The reports required under section 512(l)(3)
of the Federal Food, Drug, and Cosmetic Act, as added by subsection (a),
shall be separate from periodic drug experience reports that are
required under section 514.80(b)(4) of title 21, Code of Federal
Regulations (as in effect on the date of the enactment of this title).
SEC. [NOTE: 21 USC 379j-11 note.] 106. SAVINGS CLAUSE.
Notwithstanding section 5 of the Animal Drug User Fee Act of 2003
(21 U.S.C. 379j-11 note), and notwithstanding the amendments made by
this title, part 4 of subchapter C of chapter VII of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 379j-11 et seq.), as in effect on the
day before the date of the enactment of this title, shall continue to be
in effect with respect to animal drug applications and supplemental
animal drug applications (as defined in such part as of such day) that
on or after September 1, 2003, but before October 1, 2008, were accepted
by the Food and Drug Administration for filing with respect to assessing
and collecting any fee required by such part for a fiscal year prior to
fiscal year 2009.
SEC. 107. [NOTE: 21 USC 379j-11 note.] EFFECTIVE DATE.
The amendments made by sections 102, 103, and 104 shall take effect
on October 1, 2008, and fees under part 4 of subchapter C of chapter VII
of the Federal Food, Drug, and Cosmetic Act, as amended by this title,
shall be assessed for all animal drug applications and supplemental
animal drug applications received on or after such date, regardless of
the date of the enactment of this title.
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122 STAT. 3515
SEC. 108. [NOTE: 21 USC 379j-11 note.] SUNSET DATES.
(a) Authorization.--The amendments made by sections 102 and 103
cease to be effective October 1, 2013.
(b) Reporting Requirements.--The amendment made by section 104
ceases to be effective January 31, 2014.
TITLE II--ANIMAL [NOTE: Animal Generic Drug User Fee Act of 2008.]
GENERIC DRUG USER FEE
SEC. 201. SHORT TITLE; FINDINGS.
(a) [NOTE: 21 USC 301 note.] Short Title.--This title may be
cited as the ``Animal Generic Drug User Fee Act of 2008''.
(b) [NOTE: 21 USC 379j-21 note.] Findings.--Congress finds as
follows:
(1) Prompt approval of abbreviated applications for safe and
effective generic new animal drugs will reduce animal healthcare
costs and promote the well-being of animal health and the public
health.
(2) Animal health and the public health will be served by
making additional funds available for the purpose of augmenting
the resources of the Food and Drug Administration that are
devoted to the process for the review of abbreviated
applications for the approval of generic new animal drugs.
(3) The fees authorized by this title will be dedicated
toward expediting the generic new animal drug development
process and the review of abbreviated applications for generic
new animal drugs, supplemental abbreviated applications for
generic new animal drugs, and investigational submissions for
generic new animal drugs as set forth in the goals identified in
the letters from the Secretary of Health and Human Services to
the Chairman of the Committee on Energy and Commerce of the
House of Representatives and the Chairman of the Committee on
Health, Education, Labor, and Pensions of the Senate as set
forth in the Congressional Record.
SEC. 202. FEES RELATING TO ABBREVIATED APPLICATIONS FOR GENERIC
NEW ANIMAL DRUGS.
(a) Redesignation.--Chapter VII (21 U.S.C. 371 et seq.) is amended
by redesignating sections 741, 742, and 746 [NOTE: 21 USC 379k, 379l,
and 379o.] as sections 745, 746, and 749, respectively.
(b) Authority To Assess and Use Generic New Animal Drug Fees.--
Subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 379f et seq.) is amended by adding at the end the following:
``PART 5--FEES RELATING TO GENERIC NEW ANIMAL DRUGS
``SEC. 741. [NOTE: 21 USC 379j-21.] AUTHORITY TO ASSESS AND USE
GENERIC NEW ANIMAL DRUG FEES.
``(a) Types of Fees.--Beginning with respect to fiscal year 2009,
the Secretary shall assess and collect fees in accordance with this
section as follows:
``(1) Abbreviated application fee.--
``(A) In general.--Each [NOTE: Effective date.]
person that submits, on or after July 1, 2008, an
abbreviated application for a generic
[[Page 3516]]
122 STAT. 3516
new animal drug shall be subject to a fee as established
in subsection (b) for such an application.
``(B) Payment.--The fee required by subparagraph (A)
shall be due upon submission of the abbreviated
application.
``(C) Exception for previously filed application.--
If an abbreviated application was submitted by a person
that paid the fee for such application, was accepted for
filing, and was not approved or was withdrawn (without a
waiver or refund), the submission of an abbreviated
application for the same product by the same person (or
the person's licensee, assignee, or successor) shall not
be subject to a fee under subparagraph (A).
``(D) Refund of fee if application refused for
filing.--The Secretary shall refund 75 percent of the
fee paid under subparagraph (B) for any abbreviated
application which is refused for filing.
``(E) Refund of fee if application withdrawn.--If an
abbreviated application is withdrawn after the
application was filed, the Secretary may refund the fee
or portion of the fee paid under subparagraph (B) if no
substantial work was performed on the application after
the application was filed. The Secretary shall have the
sole discretion to refund the fee under this
subparagraph. A determination by the Secretary
concerning a refund under this subparagraph shall not be
reviewable.
``(2) Generic new animal drug product fee.--Each person--
``(A) who is named as the applicant in an
abbreviated application or supplemental abbreviated
application for a generic new animal drug product which
has been submitted for listing under section 510, and
``(B) who, after September 1, 2008, had pending
before the Secretary an abbreviated application or
supplemental abbreviated application,
shall pay for each such generic new animal drug product the
annual fee established in subsection (b). Such fee shall be
payable for the fiscal year in which the generic new animal drug
product is first submitted for listing under section 510, or is
submitted for relisting under section 510 if the generic new
animal drug product has been withdrawn from listing and
relisted. [NOTE: Deadline.] After such fee is paid for that
fiscal year, such fee shall be payable on or before January 31
of each year. Such fee shall be paid only once for each generic
new animal drug product for a fiscal year in which the fee is
payable.
``(3) Generic new animal drug sponsor fee.--
``(A) In general.--Each person--
``(i) who meets the definition of a generic
new animal drug sponsor within a fiscal year, and
``(ii) who, after September 1, 2008, had
pending before the Secretary an abbreviated
application, a supplemental abbreviated
application, or an investigational submission,
shall be assessed an annual fee established under
subsection (b). [NOTE: Deadline.] The fee shall be
paid on or before January 31 of each year.
[[Page 3517]]
122 STAT. 3517
``(B) Amount of fee.--Each generic new animal drug
sponsor shall pay only 1 such fee each fiscal year, as
follows:
``(i) 100 percent of the amount of the generic
new animal drug sponsor fee published for that
fiscal year under subsection (c)(3) for an
applicant with more than 6 approved abbreviated
applications.
``(ii) 75 percent of the amount of the generic
new animal drug sponsor fee published for that
fiscal year under subsection (c)(3) for an
applicant with more than 1 and fewer than 7
approved abbreviated applications.
``(iii) 50 percent of the amount of the
generic new animal drug sponsor fee published for
that fiscal year under subsection (c)(3) for an
applicant with 1 or fewer approved abbreviated
applications.
``(b) Fee Amounts.--Except as provided in subsection (a)(1) and
subsections (c), (d), (f), and (g), the fees required under subsection
(a) shall be established to generate fee revenue amounts as follows:
``(1) Total fee revenues for application fees.--The total
fee revenues to be collected in abbreviated application fees
under subsection (a)(1) shall be $1,449,000 for fiscal year
2009, $1,532,000 for fiscal year 2010, $1,619,000 for fiscal
year 2011, $1,712,000 for fiscal year 2012, and $1,809,000 for
fiscal year 2013.
``(2) Total fee revenues for product fees.--The total fee
revenues to be collected in generic new animal drug product fees
under subsection (a)(2) shall be $1,691,000 for fiscal year
2009, $1,787,000 for fiscal year 2010, $1,889,000 for fiscal
year 2011, $1,997,000 for fiscal year 2012, and $2,111,000 for
fiscal year 2013.
``(3) Total fee revenues for sponsor fees.--The total fee
revenues to be collected in generic new animal drug sponsor fees
under subsection (a)(3) shall be $1,691,000 for fiscal year
2009, $1,787,000 for fiscal year 2010, $1,889,000 for fiscal
year 2011, $1,997,000 for fiscal year 2012, and $2,111,000 for
fiscal year 2013.
``(c) Adjustments.--
``(1) Workload adjustment.--The fee revenues shall be
adjusted each fiscal year after fiscal year 2009 to reflect
changes in review workload. With respect to such adjustment:
``(A) This adjustment shall be determined by the
Secretary based on a weighted average of the change in
the total number of abbreviated applications for generic
new animal drugs, manufacturing supplemental abbreviated
applications for generic new animal drugs,
investigational generic new animal drug study
submissions, and investigational generic new animal drug
protocol submissions submitted to the
Secretary. [NOTE: Federal Register, publication.] The
Secretary shall publish in the Federal Register the fees
resulting from this adjustment and the supporting
methodologies.
``(B) Under no circumstances shall this workload
adjustment result in fee revenues for a fiscal year that
are less than the fee revenues for that fiscal year
established in subsection (b).
``(2) Final year adjustment.--For fiscal year 2013, the
Secretary may further increase the fees to provide for up to
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122 STAT. 3518
3 months of operating reserves of carryover user fees for the
process for the review of abbreviated applications for generic
new animal drugs for the first 3 months of fiscal year 2014. If
the Food and Drug Administration has carryover balances for the
process for the review of abbreviated applications for generic
new animal drugs in excess of 3 months of such operating
reserves, then this adjustment shall not be made. If this
adjustment is necessary, then the rationale for the amount of
the increase shall be contained in the annual notice setting
fees for fiscal year 2013.
``(3) [NOTE: Deadline. Effective date.] Annual fee
setting.--The Secretary shall establish, 60 days before the
start of each fiscal year beginning after September 30, 2008,
for that fiscal year, abbreviated application fees, generic new
animal drug sponsor fees, and generic new animal drug product
fees based on the revenue amounts established under subsection
(b) and the adjustments provided under this subsection.
``(4) Limit.--The total amount of fees charged, as adjusted
under this subsection, for a fiscal year may not exceed the
total costs for such fiscal year for the resources allocated for
the process for the review of abbreviated applications for
generic new animal drugs.
``(d) Fee Waiver or Reduction.--The Secretary shall grant a waiver
from or a reduction of 1 or more fees assessed under subsection (a)
where the Secretary finds that the generic new animal drug is intended
solely to provide for a minor use or minor species indication.
``(e) Effect of Failure To Pay Fees.--An abbreviated application for
a generic new animal drug submitted by a person subject to fees under
subsection (a) shall be considered incomplete and shall not be accepted
for filing by the Secretary until all fees owed by such person have been
paid. An investigational submission for a generic new animal drug that
is submitted by a person subject to fees under subsection (a) shall be
considered incomplete and shall not be accepted for review by the
Secretary until all fees owed by such person have been paid. The
Secretary may discontinue review of any abbreviated application for a
generic new animal drug, supplemental abbreviated application for a
generic new animal drug, or investigational submission for a generic new
animal drug from a person if such person has not submitted for payment
all fees owed under this section by 30 days after the date upon which
they are due.
``(f) Assessment of Fees.--
``(1) Limitation.--Fees may not be assessed under subsection
(a) for a fiscal year beginning after fiscal year 2008 unless
appropriations for salaries and expenses of the Food and Drug
Administration for such fiscal year (excluding the amount of
fees appropriated for such fiscal year) are equal to or greater
than the amount of appropriations for the salaries and expenses
of the Food and Drug Administration for the fiscal year 2003
(excluding the amount of fees appropriated for such fiscal year)
multiplied by the adjustment factor applicable to the fiscal
year involved.
``(2) Authority.--If the Secretary does not assess fees
under subsection (a) during any portion of a fiscal year because
of paragraph (1) and if at a later date in such fiscal year the
Secretary may assess such fees, the Secretary may assess
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122 STAT. 3519
and collect such fees, without any modification in the rate, for
abbreviated applications, generic new animal drug sponsors, and
generic new animal drug products at any time in such fiscal year
notwithstanding the provisions of subsection (a) relating to the
date fees are to be paid.
``(g) Crediting and Availability of Fees.--
``(1) In general.--Fees authorized under subsection (a)
shall be collected and available for obligation only to the
extent and in the amount provided in advance in appropriations
Acts. Such fees are authorized to be appropriated to remain
available until expended. Such sums as may be necessary may be
transferred from the Food and Drug Administration salaries and
expenses appropriation account without fiscal year limitation to
such appropriation account for salary and expenses with such
fiscal year limitation. The sums transferred shall be available
solely for the process for the review of abbreviated
applications for generic new animal drugs.
``(2) Collections and appropriation acts.--
``(A) In general.--The fees authorized by this
section--
``(i) shall be retained in each fiscal year in
an amount not to exceed the amount specified in
appropriation Acts, or otherwise made available
for obligation for such fiscal year; and
``(ii) shall only be collected and available
to defray increases in the costs of the resources
allocated for the process for the review of
abbreviated applications for generic new animal
drugs (including increases in such costs for an
additional number of full-time equivalent
positions in the Department of Health and Human
Services to be engaged in such process) over such
costs, excluding costs paid from fees collected
under this section, for fiscal year 2008
multiplied by the adjustment factor.
``(B) Compliance.--The Secretary shall be considered
to have met the requirements of subparagraph (A)(ii) in
any fiscal year if the costs funded by appropriations
and allocated for the process for the review of
abbreviated applications for generic new animal drugs--
``(i) are not more than 3 percent below the
level specified in subparagraph (A)(ii); or
``(ii)(I) are more than 3 percent below the
level specified in subparagraph (A)(ii), and fees
assessed for the fiscal year following the
subsequent fiscal year are decreased by the amount
in excess of 3 percent by which such costs fell
below the level specified in subparagraph (A)(ii);
and
``(II) such costs are not more than 5 percent
below the level specified in subparagraph (A)(ii).
``(3) Authorization of appropriations.--There are authorized
to be appropriated for fees under this section--
``(A) $4,831,000 for fiscal year 2009;
``(B) $5,106,000 for fiscal year 2010;
``(C) $5,397,000 for fiscal year 2011;
``(D) $5,706,000 for fiscal year 2012; and
``(E) $6,031,000 for fiscal year 2013;
[[Page 3520]]
122 STAT. 3520
as adjusted to reflect adjustments in the total fee revenues
made under this section and changes in the total amounts
collected by abbreviated application fees, generic new animal
drug sponsor fees, and generic new animal drug product fees.
``(4) Offset.--If the sum of the cumulative amount of fees
collected under this section for the fiscal years 2009 through
2011 and the amount of fees estimated to be collected under this
section for fiscal year 2012 exceeds the cumulative amount
appropriated under paragraph (3) for the fiscal years 2009
through 2012, the excess amount shall be credited to the
appropriation account of the Food and Drug Administration as
provided in paragraph (1), and shall be subtracted from the
amount of fees that would otherwise be authorized to be
collected under this section pursuant to appropriation Acts for
fiscal year 2013.
``(h) Collection of Unpaid Fees.--In [NOTE: Deadline.] any case
where the Secretary does not receive payment of a fee assessed under
subsection (a) within 30 days after it is due, such fee shall be treated
as a claim of the United States Government subject to subchapter II of
chapter 37 of title 31, United States Code.
``(i) Written Requests for Waivers, Reductions, and Refunds.--
To [NOTE: Deadline.] qualify for consideration for a waiver or
reduction under subsection (d), or for a refund of any fee collected in
accordance with subsection (a), a person shall submit to the Secretary a
written request for such waiver, reduction, or refund not later than 180
days after such fee is due.
``(j) Construction.--This section may not be construed to require
that the number of full-time equivalent positions in the Department of
Health and Human Services, for officers, employees, and advisory
committees not engaged in the process of the review of abbreviated
applications for generic new animal drugs, be reduced to offset the
number of officers, employees, and advisory committees so engaged.
``(k) Definitions.--In this section and section 742:
``(1) Abbreviated application for a generic new animal
drug.--The terms `abbreviated application for a generic new
animal drug' and `abbreviated application' mean an abbreviated
application for the approval of any generic new animal drug
submitted under section 512(b)(2). Such term does not include a
supplemental abbreviated application for a generic new animal
drug.
``(2) Adjustment factor.--The term `adjustment factor'
applicable to a fiscal year is the Consumer Price Index for all
urban consumers (all items; United States city average) for
October of the preceding fiscal year divided by--
``(A) for purposes of subsection (f)(1), such Index
for October 2002; and
``(B) for purposes of subsection (g)(2)(A)(ii), such
Index for October 2007.
``(3) Costs of resources allocated for the process for the
review of abbreviated applications for generic new animal
drugs.--The term `costs of resources allocated for the process
for the review of abbreviated applications for generic new
animal drugs' means the expenses incurred in connection with the
process for the review of abbreviated applications for generic
new animal drugs for--
[[Page 3521]]
122 STAT. 3521
``(A) officers and employees of the Food and Drug
Administration, contractors of the Food and Drug
Administration, advisory committees consulted with
respect to the review of specific abbreviated
applications, supplemental abbreviated applications, or
investigational submissions, and costs related to such
officers, employees, committees, and contractors,
including costs for travel, education, and recruitment
and other personnel activities;
``(B) management of information, and the
acquisition, maintenance, and repair of computer
resources;
``(C) leasing, maintenance, renovation, and repair
of facilities and acquisition, maintenance, and repair
of fixtures, furniture, scientific equipment, and other
necessary materials and supplies; and
``(D) collecting fees under this section and
accounting for resources allocated for the review of
abbreviated applications, supplemental abbreviated
applications, and investigational submissions.
``(4) Final dosage form.--The term `final dosage form'
means, with respect to a generic new animal drug product, a
finished dosage form which is approved for administration to an
animal without substantial further manufacturing. Such term
includes generic new animal drug products intended for mixing in
animal feeds.
``(5) Generic new animal drug.--The term `generic new animal
drug' means a new animal drug that is the subject of an
abbreviated application.
``(6) Generic new animal drug product.--The term `generic
new animal drug product' means each specific strength or potency
of a particular active ingredient or ingredients in final dosage
form marketed by a particular manufacturer or distributor, which
is uniquely identified by the labeler code and product code
portions of the national drug code, and for which an abbreviated
application for a generic new animal drug or a supplemental
abbreviated application has been approved.
``(7) Generic new animal drug sponsor.--The term `generic
new animal drug sponsor' means either an applicant named in an
abbreviated application for a generic new animal drug that has
not been withdrawn by the applicant and for which approval has
not been withdrawn by the Secretary, or a person who has
submitted an investigational submission for a generic new animal
drug that has not been terminated or otherwise rendered inactive
by the Secretary.
``(8) Investigational submission for a generic new animal
drug.--The terms `investigational submission for a generic new
animal drug' and `investigational submission' mean--
``(A) the filing of a claim for an investigational
exemption under section 512(j) for a generic new animal
drug intended to be the subject of an abbreviated
application or a supplemental abbreviated application;
or
``(B) the submission of information for the purpose
of enabling the Secretary to evaluate the safety or
effectiveness of a generic new animal drug in the event
of the filing of an abbreviated application or
supplemental abbreviated application for such drug.
[[Page 3522]]
122 STAT. 3522
``(9) Person.--The term `person' includes an affiliate
thereof (as such term is defined in section 735(11)).
``(10) Process for the review of abbreviated applications
for generic new animal drugs.--The term `process for the review
of abbreviated applications for generic new animal drugs' means
the following activities of the Secretary with respect to the
review of abbreviated applications, supplemental abbreviated
applications, and investigational submissions:
``(A) The activities necessary for the review of
abbreviated applications, supplemental abbreviated
applications, and investigational submissions.
``(B) The issuance of action letters which approve
abbreviated applications or supplemental abbreviated
applications or which set forth in detail the specific
deficiencies in abbreviated applications, supplemental
abbreviated applications, or investigational submissions
and, where appropriate, the actions necessary to place
such applications, supplemental applications, or
submissions in condition for approval.
``(C) The inspection of generic new animal drug
establishments and other facilities undertaken as part
of the Secretary's review of pending abbreviated
applications, supplemental abbreviated applications, and
investigational submissions.
``(D) Monitoring of research conducted in connection
with the review of abbreviated applications,
supplemental abbreviated applications, and
investigational submissions.
``(E) The development of regulations and policy
related to the review of abbreviated applications,
supplemental abbreviated applications, and
investigational submissions.
``(F) Development of standards for products subject
to review.
``(G) Meetings between the agency and the generic
new animal drug sponsor.
``(H) Review of advertising and labeling prior to
approval of an abbreviated application or supplemental
abbreviated application, but not after such application
has been approved.
``(11) Supplemental abbreviated application for generic new
animal drug.--The terms `supplemental abbreviated application
for a generic new animal drug' and `supplemental abbreviated
application' mean a request to the Secretary to approve a change
in an approved abbreviated application.''.
SEC. 203. ACCOUNTABILITY AND REPORTS.
Part 5 of subchapter C of chapter VII of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 379f et seq.), as added by section 202, is
amended by inserting after section 741 the following:
``SEC. 742. [NOTE: 21 USC 379j-22.] REAUTHORIZATION; REPORTING
REQUIREMENTS.
``(a) Performance Reports.--Beginning [NOTE: Effective date.]
with fiscal year 2009, not later than 60 days after the end of each
fiscal year during which fees are collected under this part, the
Secretary shall prepare and submit to the Committee on Health,
Education, Labor, and Pensions of the Senate, and the Committee on
Energy and Commerce of the House of Representatives a report concerning
the progress of the Food and Drug Administration in achieving the
[[Page 3523]]
122 STAT. 3523
goals identified in the letters described in section 201(3) of the
Animal Generic Drug User Fee Act of 2008 toward expediting the generic
new animal drug development process and the review of abbreviated
applications for generic new animal drugs, supplemental abbreviated
applications for generic new animal drugs, and investigational
submissions for generic new animal drugs during such fiscal year.
``(b) Fiscal Report.--Beginning [NOTE: Effective date.] with
fiscal year 2009, not later than 120 days after the end of each fiscal
year during which fees are collected under this part, the Secretary
shall prepare and submit to Committee on Health, Education, Labor, and
Pensions of the Senate and the Committee on Energy and Commerce of the
House of Representatives a report on the implementation of the authority
for such fees during such fiscal year and the use, by the Food and Drug
Administration, of the fees collected during such fiscal year for which
the report is made.
``(c) Public Availability.--The [NOTE: Web site.] Secretary shall
make the reports required under subsections (a) and (b) available to the
public on the Internet Web site of the Food and Drug Administration.
``(d) Reauthorization.--
``(1) Consultation.--In [NOTE: Recommenda- tions.]
developing recommendations to present to Congress with respect
to the goals, and plans for meeting the goals, for the process
for the review of abbreviated applications for generic new
animal drugs for the first 5 fiscal years after fiscal year
2013, and for the reauthorization of this part for such fiscal
years, the Secretary shall consult with--
``(A) the Committee on Energy and Commerce of the
House of Representatives;
``(B) the Committee on Health, Education, Labor, and
Pensions of the Senate;
``(C) scientific and academic experts;
``(D) veterinary professionals;
``(E) representatives of patient and consumer
advocacy groups; and
``(F) the regulated industry.
``(2) Prior public input.--Prior to beginning negotiations
with the regulated industry on the reauthorization of this part,
the Secretary shall--
``(A) [NOTE: Notice. Federal Register,
publication.] publish a notice in the Federal Register
requesting public input on the reauthorization;
``(B) hold a public meeting at which the public may
present its views on the reauthorization, including
specific suggestions for changes to the goals referred
to in subsection (a);
``(C) provide a period of 30 days after the public
meeting to obtain written comments from the public
suggesting changes to this part; and
``(D) [NOTE: Web site.] publish the comments on
the Food and Drug Administration's Internet Web site.
``(3) Periodic consultation.--Not [NOTE: Deadlines.] less
frequently than once every 4 months during negotiations with the
regulated industry, the Secretary shall hold discussions with
representatives of veterinary, patient, and consumer advocacy
groups to continue discussions of their views on the
reauthorization
[[Page 3524]]
122 STAT. 3524
and their suggestions for changes to this part as expressed
under paragraph (2).
``(4) Public review of recommendations.--After negotiations
with the regulated industry, the Secretary shall--
``(A) present the recommendations developed under
paragraph (1) to the congressional committees specified
in such paragraph;
``(B) [NOTE: Federal Register, publication.]
publish such recommendations in the Federal Register;
``(C) provide for a period of 30 days for the public
to provide written comments on such recommendations;
``(D) hold a meeting at which the public may present
its views on such recommendations; and
``(E) after consideration of such public views and
comments, revise such recommendations as necessary.
``(5) Transmittal of recommendations.--
Not [NOTE: Deadline.] later than January 15, 2013, the
Secretary shall transmit to Congress the revised recommendations
under paragraph (4), a summary of the views and comments
received under such paragraph, and any changes made to the
recommendations in response to such views and comments.
``(6) Minutes of negotiation meetings.--
``(A) Public availability.--Before [NOTE: Web
site.] presenting the recommendations developed under
paragraphs (1) through (5) to Congress, the Secretary
shall make publicly available, on the Internet Web site
of the Food and Drug Administration, minutes of all
negotiation meetings conducted under this subsection
between the Food and Drug Administration and the
regulated industry.
``(B) Content.--The minutes described under
subparagraph (A) shall summarize any substantive
proposal made by any party to the negotiations as well
as significant controversies or differences of opinion
during the negotiations and their resolution.''.
SEC. 204. SUNSET DATES.
(a) [NOTE: 21 USC 379j-21 note.] Authorization.--The amendments
made by section 202 shall cease to be effective October 1, 2013.
(b) [NOTE: 21 USC 379j-22 note.] Reporting Requirements.--The
amendment made by section 203 shall cease to be effective January 31,
2014.
TITLE III--TECHNICAL CORRECTIONS TO FDAAA
SEC. 301. CONSIDERATION OF CERTAIN PETITIONS.
Subparagraph (A) of section 505(q)(1) (21 U.S.C. 355(q)(1)) is
amended by adding at the end the following:
``Consideration of the petition shall be separate and
apart from review and approval of any application.''.
SEC. 302. REGISTRY AND RESULTS DATA BANK.
Paragraph (3) of section 402(j) of the Public Health Service Act (42
U.S.C. 282(j)) is amended--
(1) in the matter preceding clause (i) in subparagraph (C),
by striking ``the following elements'' and all that follows
through ``520(m) of such Act:'' and inserting ``for each
applicable
[[Page 3525]]
122 STAT. 3525
clinical trial for a drug that is approved under section 505 of
the Federal Food, Drug, and Cosmetic Act or licensed under
section 351 of this Act or a device that is cleared under
section 510(k) of the Federal Food, Drug, and Cosmetic Act or
approved under section 515 or 520(m) of such Act, the following
elements:''; and
(2) in clauses (i) and (iii) of subparagraph (I), by
striking the term ``drugs described in subparagraph (C)'' each
place such term appears and inserting ``applicable clinical
trials described in subparagraph (C)''.
Approved August 14, 2008.
LEGISLATIVE HISTORY--H.R. 6432:
---------------------------------------------------------------------------
HOUSE REPORTS: No. 110-804 (Comm. on Energy and Commerce).
CONGRESSIONAL RECORD, Vol. 154 (2008):
July 30, considered and passed House.
Aug. 1, considered and passed Senate.